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Terminated

Stealth Station Cranial Application v.4.5

FDA Recall Z-0711-05 · Posted 2005-04-16

Recalling FirmMedtronic Surgical Navigation Technologies, Inc
Recall StatusTerminated
Product CodeHAW
Date Initiated2005-01-28
Date Terminated2005-04-15
Product Quantity53 systems with software version 4.5

Reason for Recall

The Stealth Station Cranial Application Version 4.5 contains a software anomaly, which may present a hazard to the patient.

Firm Action

Customers were sent notification letters dated 01/28/05 and 02/02/05.

Root Cause

Other

Distribution Pattern

Domestic distribution: FL, CO, AZ, TX, AR, MT, OK, IL, PA, NY, LA, WI, NC, ND, CA, GA, AL, OR, WY, WA, OH, NV. Foreign distribution: Belgium, Czech Republic, China (Malaysia). No military or VA facilites.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K954276STEALTHSTATIONSurgical Navigation Technologies, Inc. · 1996-01-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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